Senior QA Specialist Technical Support
Lonza
Slough,UK
35d ago

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success.

Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.

Our vision :

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission :

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

Do you want to help us as we shape the future of this great organization?

Job Description Summary

An excellent opportunity exists for a Senior QA Specialist Technical Support to join our QA Team. This is permanent position which will be based out of our Slough facility.

This role is a weekend working position with a choice of Tuesday - Saturday or Sunday - Thursday shift and will attract a 15% shift uplift.

Role Purpose and Duties :

As the Senior QA Specialist Technical Support you will enable site operations performance by managing and supporting GMP issues through QMS processes, site governance mechanisms and senior QA leadership.

Enable site operations compliance by acting as cGMP SME and by designing, implementing, managing, and enforcing quality processes on site to encourage a ""quality at point of doing" culture with a focus on effectiveness (doing the right things) .

Supporting senior QA leadership and QP decision making to drive continuous improvement and "fitness for purpose".

Key responsibilities :

  • Provides shoulder to shoulder review, approval and QA Technical support to key business partners for the management of quality records e.
  • g. Deviations, CAPA, Change Controls, Investigations

  • Utilises knowledge of GMP and quality processes within the functional areas to :
  • Manage and escalate Major and Critical compliance issues through the site QMS processes e.g. deviations and CAPAs
  • to actively identify, suggest and participate in continuous improvement activities
  • Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment
  • Maintain and promote a state of audit readiness
  • Actively suggest, initiate, participate and contribute to PQS process improvements initiatives and projects.
  • Provides QA SME support at departmental Local Quality Councils and project meetings
  • Provides shoulder to shoulder review, approval and QA Technical support to key business partners for the management of quality records e.
  • g. Deviations, CAPA, Change Controls, Investigations

    Interested?

    What we need you to have :

  • BSc (or equivalent) in Science or QA discipline
  • Significant on the job work experience in a GMP environment, ideally in the Biologics or Pharmaceutical manufacturing industry
  • Experiance of supporting supplychain or manufacturing in a QA capacity would be highly advatageous.
  • Knowledge of European and USA GxP guidelines
  • IT literate - MS Office Word, Explorer, Excel, Access, Outlook
  • Database familiarity with data entry / searches / queries
  • Excellent communication skills (verbal and written)
  • Excellent risk based decision-making and problem solving skills.
  • Accurate data entry skills. Attention to detail.
  • Ability to meet strict deadlines.
  • Previous QMS process design, implementation, management and utilisation experience
  • Significant Scientific / GXP Knowledge
  • Excellent organisational & planning skills
  • Ability to work in team and solo capacity
  • Significant experience in risk management and project management
  • Who You are :

    A proactive and pragmatic, risk based thinker who is an accountable, reliable, flexible, motivated, responsible, ambitious, action orientated team player.

    What we offer

    We offer an excellent work environment where you can develop your skills and knowledge, the opportunity to work in a team of highly collaborative experts in a fun and dynamic atmosphere, and competitive salary and benefits.

    At Lonza we invest in great people. We encourage our employees to challenge themselves, and we offer an environment that fosters creativity and success.

    With headquarters in Basel, Switzerland, we operate production, R&D and business sites around the world, including Europe, North America and Asia.

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